Write and review validation (verification, IOQ, PQ, and PV) documents (protocols, reports, risk assessments, etc.), conduct or coordinate performance testing and perform or oversee the validation of facilities, equipment, utilities, laboratories, equipment, and processes. Involved in validation monitoring activities, which include audits with the system owner and review of operational documents. Participates in process development and process validation activities, including cleaning, shipping and continued process verification.
Essential Duties and Responsibilities:
- Write standard operating procedures describing process validation principles and activities as well as Validation Plans for functional areas and/or projects focusing on process and cleaning validation.
- Actively participate during all phases of process validation: evaluate projects, provide guidance and technical information to co-workers. Write and review validation documents to support FAT, commissioning, IOQ, PQ, PV activities including protocols and final reports.
- Write and review validation documents related to facilities, equipment, utilities, laboratories and equipment, or process validation systems comprising check for compliance with corporate standards, regulatory requirements and technical expertise.
- Review engineering drawings (P&IDs, against, as-built), TOP documentation.
- Review validation packages for completeness and accuracy, sound rationale, compliance with validation policies and procedures, and accurate data analysis. Compare results against acceptance criteria and bring exceptions and deviations to management's attention. Recommend to management as to the acceptance and release of qualified systems.
- Execute and/or coordinate/supervise execution of process, cleaning, shipping and continued process verification activities.
- Executes process validation for new processes as well as legacy processes and requalifications.
- All employees are responsible for the general upkeep of work and shared spaces.
- Other duties as assigned.
- 5-6 years of experience in Validation or Quality Departments or an equivalent combination of education and experience.
- Validation experience including one or more of the following areas: process validation, cleaning validation, shipping validation, process development, media fill simulations, air flow visualization, validation, process equipment validation and continued process verification.
- Experience drafting Validation Master Plans and Validation Project Plans.
- B.A. or B.S. in Biology, Biochemistry, Engineering or related science
Skills and Knowledge:
- Knowledge and practical experience using statistics in validation including statistical process control and use of statistics to set acceptance criteria and evaluate process data.
- Knowledge of the regulatory and cGMP regulations for pharmaceutical manufacturing operations, and validation procedures and practices.
- Demonstrated ability to develop and present site-wide training sessions.
- Demonstrated ability to lead process validation execution teams.
- Ability to communicate knowledge to peers and colleagues from other departments requiring a thorough understanding of processes, equipment, and facilities.
- Ability to independently perform requalification of manufacturing processes.
- Excellent verbal and written communication, interpersonal and communication skills required.
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers/filing cabinets and fax machines.
This position may also be required to work in a lab setting and may encounter various solutions and chemicals. This position works with standard laboratory equipment.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is regularly required to see, talk and hear. The employee frequently is required to stand; walk; bend; lift up to 50 pounds; use arms, hands and fingers for various activities. This position may stand or remain sedentary for long periods of time. This position routinely works with large pieces of equipment.
Aldevron is a custom manufacturing organization that provides plasmid, protein and antibody development and production services. Headquartered in Fargo, ND with locations in Madison, WI and Freiburg, Germany we constantly look to innovate and advance life science through collaborative partnerships. Aldevron works with leaders in pharmaceutical, biotech and research institutions around the world to accelerate the development of drug, treatment and preventions for numerous diseases and genetic disorders. Our reputation for innovative solutions for our clients has allowed us to expand our organization and offerings in all service platforms. We are working in a landmark moment in the history of life science.